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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K180999
Device Name Mygen V-1000 RF System
Applicant
RF Medical Co., Ltd.
#502, 503, 506, 511, 254, Beotkkot-Ro, Geumcheon-Gu
Seoul,  KR
Applicant Contact Kwang S. Choi
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/16/2018
Decision Date 12/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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